Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER Capsules

A Multiple-Dose, Randomized, Open-Label, Parallel Pharmacokinetic Comparison Study of TNX-102 SL (Cyclobenzaprine Hydrochloride [HCl] Sublingual Tablets) 2 x 2.8 mg Versus AMRIX® (Cyclobenzaprine HCl ER Capsules) 30 mg in Healthy Subjects Under Fasting Conditions

This will be a single center, comparative pharmacokinetic, open-label, randomized, multiple-dose, 1-period, 2-arm, parallel study of TNX-102 SL 5.6 mg (administered as 2 x 2.8 mg tablets) to AMRIX® (cyclobenzaprine hydrochloride [HCl] extended-release [ER] capsules), 30 mg.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: TNX-102 SL 5.6 mg; Drug: Amrix 30 mg

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Quebec City, Quebec, Canada, G1P 0A2
      • Quebec City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, non-smoker, ≥18 and ≤75 years of age (Treatment A) or ≥18 and ≤65 years of age (Treatment B), with Body Mass Index (BMI) >18.5 and <30.0 kg/m2
• Females of childbearing potential must be willing to use a medically acceptable method of birth control throughout the study
• Capable of consent

Exclusion Criteria:

• Any clinically significant abnormality or abnormal laboratory test results found during medical screening
• Positive hepatitis B, hepatitis C, HIV, urine drug screen, urine cotinine test, or alcohol breath test at screening
• History of allergic reactions to cyclobenzaprine, any of the formulation component, or other related drugs
• Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first study drug administration
• Positive pregnancy test at screening
• Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities at screening
• History of significant alcohol or drug abuse within one year prior to screening
• Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days prior to the first dosing or concomitant participation in an investigational study involving no drug administration
• Use of medication other than topical products without significant systemic absorption and hormonal contraceptives
• Donation of plasma within 7 days prior to dosing, or significant loss of blood within 54 days of dosing.
• Abnormal hemoglobin and hematocrit levels at screening
• Breast-feeding subject
• Presence of dentures, tongue piercings with ongoing use of tongue studs/jewelry, orthodontic braces, or surgical manipulations of the tongue

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment A (TNX-102 SL); 2 x TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 2.8 mg once daily for 20 consecutive days	Drug: TNX-102 SL 5.6 mg; Subjects randomly assigned to this treatment will place 2 tablets simultaneously under the tongue until dissolved, and not to crush or chew them.; Other Names: cyclobenzaprine HCl
ACTIVE_COMPARATOR: Treatment B (AMRIX); 1 x AMRIX ER capsule 30 mg once daily for 20 consecutive days	Drug: Amrix 30 mg; Subjects randomly assigned to this treatment will swallow 1 capsules with a cup of water, and not to crush or chew it.; Other Names: cyclobenzaprine HCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Steady-State Area Under the Plasma Concentration Versus Time Curve (AUC-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg	Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-last dose).	Day 1 to Day 27
Peak Steady-State Plasma Concentration (Cmax-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg	Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-dose).	Day 1 to Day 27
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 5.6 mg versus AMRIX 30 mg	TEAEs will be collected throughout the study and are summarized descriptively by treatment, relationship, and severity for all subjects dosed.	Day 1 to Day 47
Peak Steady-State Plasma Concentration (Cmax-ss) of norcyclobenzaprine from TNX-102 SL 5.6 mg versus AMRIX 30 mg	Blood samples are collected from pre-dose on Day 1 up until Day 47 (648 hours post-last dose).	Day 1 to Day 47

Collaborators and Investigators

• Sponsor: Tonix Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 29, 2018
• Primary Completion (ACTUAL): April 9, 2018
• Study Completion (ACTUAL): April 9, 2018

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 21, 2018
• First Posted (ACTUAL): February 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Tricyclic; Neuromuscular Agents; Adrenergic Uptake Inhibitors; Muscle Relaxants, Central; Amitriptyline; Cyclobenzaprine
• Other Study ID Numbers: TNX-CY-F106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No